实验室认可要求与室内质控规范课件.pptVIP

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实验室认可要求与室内质控规范课件.ppt

实验室认可要求与室内质控规范课件

周之炜 QSD Product Manager North ChinaCAP、ISO认证和质控的核心理念;质量管理概览;质控目的的新理解;;第三方质控品的特殊重要性;;;The need for independent laboratory quality control is fundamental! 最根本的是要独立地进行实验室质控。 Independent QC begins by having control materials that are independent of the calibration materials. 独立质控首先要求使用独立于校准品的质控品(C24A3 7.3)。 It is also good practice to have control materials that are made by a different manufacturer than the test system, as confirmed by FDAs recommendation for the use of quality control materials made by other companies to increase the assurance that these devices are performing succ

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